PharmaTrackBatch traceability ERP
21 CFR Part 11 · Schedule M

Every batch traceable, every signature provable.

PharmaTrack links raw material to finished pack across the manufacturing floor — goods receipt, batch genealogy, QA release, GS1 serialization, packaging-line verification and dispatch — with an append-only audit trail that cannot be edited through the application.

Immutable audit trail ALCOA+ data integrity GS1 DataMatrix & QR eBMR Multi-plant, multi-company
Pharmaceutical packaging line with white cartons carrying 2D DataMatrix codes on a manufacturing conveyor
Packaging-line view: serialized cartons, marking and in-line verification.
The platform

The controls follow the batch through production

PharmaTrack connects material receipt, batch genealogy, QA release, serialization and packaging-line verification. Where a prerequisite is required, it is enforced by the system rather than relying only on the user interface.

Raw material drum on pallet with traceability identification tag
Screen one

Raw material & batch linking

Goods receipt through to batch genealogy, with the release gate that decides whether anything downstream may happen at all.

  • Vendor, GRN, COA and retest dates on every lot
  • Material issued to a batch, quantity reconciled
  • No QA release signature, no serialization — enforced
GS1 DataMatrix code being printed on pharmaceutical cartons on a packaging line
Screen two

Dynamic 2D & QR generator

Randomised, non-sequential serials — one per saleable unit — each carrying a complete GS1 element string, up to 500,000 in a single run.

  • AI (01) GTIN, AI (11) manufacture date, AI (17) expiry date, AI (10) lot, AI (21) serial
  • GS1 DataMatrix for print, QR preview for on-screen check
  • Serial numbers are permanent and never reissued
Handheld scanner verifying a 2D code on a pharmaceutical carton
Screen three

Packaging line integration

Handheld and fixed scanners verify the printed symbol against the record before a pack is allowed to move, with an e-signature gate on every label export.

  • Scan-to-verify, with mismatches blocked at the line
  • Label files released only against a signed authorisation
  • Short-lived export tokens, single use
Built for validation and audit review

The controls are part of the system, not just the screen

PharmaTrack implements its audit-trail, electronic-signature, access-control and workflow-sequencing controls at the data layer. This means the same rules apply whether a record is accessed through the application, a report or an authorised system operation. Final compliance depends on the validated installation, configuration and operating procedures used at your site.

An append-only audit trailUpdate, delete and truncate operations are refused for every role, and each row is hash-chained to the one before it. An altered or removed entry therefore produces a visible break in the chain.
Electronic signatures per 21 CFR 11.50Two components — user ID plus password or signing PIN. Each signature records the signer, the date and time, and the meaning of the signing, and is bound to the exact record it approved.
Changes require a new approvalIf an approved record is changed, its existing signature is invalidated. Re-approval creates a new signature, while the previous history remains visible.
Enforced sequencing of steps — 11.10(f)Serialization is refused for a batch with no live QA release. Export is refused without a signed authorisation. The order of operations is enforced by the data layer rather than only by the screen flow.
Five access levels, isolated by plantSoftware admin, company admin, plant head, QA/QC manager and store or production operator. A user cannot see another company's data or another plant's batches, and that boundary is applied at the data layer.
ALCOA+ and a complete eBMRAttributable, legible, contemporaneous, original and accurate — with the electronic batch manufacturing record reconstructable for a batch, and scanned codes traceable back to the material genealogy recorded in the system.
Immutable pharmaceutical audit trail showing linked time-stamped records and blocked direct editing
Illustrative audit-trail concept: records remain linked and original history is preserved when a correction is required.
For pharmaceutical manufacturing

Built around the way a pharmaceutical batch is controlled

PharmaTrack connects material genealogy, batch records, QA release, serialization and packaging-line verification in one traceable workflow.

Pharmaceutical formulations API & bulk drugs Contract manufacturing Multi-plant operations GS1 serialization Electronic batch records
Questions we are asked first

Before you book a call

Is PharmaTrack 21 CFR Part 11 compliant?

The software provides technical controls relevant to 21 CFR Part 11, including an append-only audit trail, dual-component electronic signatures with the 11.50 manifestation, signature-to-record binding, change-related signature invalidation, enforced sequencing and data-layer access controls. Final compliance depends on the validated installation, configuration and procedures used at your site.

Does it meet Schedule M requirements?

PharmaTrack keeps the electronic batch manufacturing record, the material genealogy behind it and the QA release decision in one place, so the relevant batch history can be reconstructed from the records maintained in the system. The extent to which the installation satisfies your site's Schedule M requirements depends on configuration, validation and operating procedures.

Can we run several plants and several companies?

Yes. The structure is many companies, each with many plants, one administrator per company, and users scoped to the plants they work in. The scoping is enforced in the database, so a report, an export and a screen all return the same rows for the same user.

What symbology do the labels use?

GS1 DataMatrix is the default for printed labels, with QR available and the same payload structure supported in either format. Labels are produced from ZPL or TSPL templates; the on-screen symbol provides a preview that can be scanned to confirm the payload before a print run.

Will it work with our existing accounting system?

There is an integration path for Tally and legacy ERP systems. The exact integration depends on the system, data and transactions involved, so tell us what you currently use and we will explain what the integration would require.

How do we see it working?

Message us on WhatsApp at +91 62629 59501 or email info@ycsin.com and we will walk you through a live batch — receipt to serialized pack — on your own product structure.

Talk to us

Tell us what your floor actually does

We would rather understand your process than pitch at you. A short call is usually enough to say whether PharmaTrack fits — and if it does not, we will say so.

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